A Novel Echocardiography-Guided Strategy for Percutateous Closure of Atrial Septal Defect Assisted by PannaWire
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 666
- 试验地点
- 2
- 主要终点
- Procedural success rate
研究概览
简要总结
Atrial septal defect (ASD) is a common congenital heart disease, and percutaneous interventional therapy is the main and effective treatment. Traditional percutaneous closure procedures are performed under fluoroscopic guidance and require contrast agents. A retrospective analysis of over 20,000 adult patients with congenital heart disease revealed that even low-dose radiation exposure was significantly associated with an increased long-term risk of malignancy. Moreover, the use of contrast agents carries the risk of allergic reactions and kidney injury. Radiation and contrast agents not only pose iatrogenic harm to patients but also limit the use of interventional techniques in special populations, such as pregnant women, patients with contrast agent allergies, or those with renal insufficiency.
To achieve radiation-free and contrast-free interventional closure procedures, researchers have developed ultrasound-guided percutaneous interventional techniques, yielding satisfactory treatment outcomes. In some cases, these techniques have even enabled cardiovascular procedures to be performed on an outpatient basis, significantly reducing hospitalization time and costs.
This project proposes a large-sample, multicenter, prospective randomized controlled study to determine whether ultrasound-guided percutaneous intervention for ASD with the assistance of specialized instruments is non-inferior to traditional fluoroscopy-guided procedures, while also offering shorter hospital stays and lower medical expenses.In addition, patients with radiation contraindications or who refuse radiation therapy, and who are willing to undergo ultrasound-guided percutaneous atrial septal defect (ASD) closure with the assistance of dedicated devices, will be enrolled in a separate observational cohort (observational cohort study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RCT Eligibility Criteria
- •Inclusion Criteria:
- •Age ≥ 2 years
- •Diagnosed with secundum-type atrial septal defect (ASD) with a diameter ≥ 6 mm and ≤ 36 mm, accompanied by right heart volume overload
- •The distance from the defect margin to the coronary sinus, inferior vena cava, superior vena cava, and pulmonary veins is ≥ 5 mm; the distance to the atrioventricular valve is ≥ 7 mm
排除标准
- •Pregnant women
- •Contrast agent allergy
- •Renal insufficiency
- •Associated cardiac malformations requiring surgical intervention
- •Right-to-left shunt ASD
- •Ostium primum ASD and sinus venosus ASD
- •Any severe infection within one month before the procedure
- •Intracardiac thrombus
- •Cohort Eligibility Criteria：
- •Inclusion Criteria:
- •Age ≥ 2 years
- •Diagnosed with secundum-type atrial septal defect (ASD) with a diameter ≥ 6 mm and ≤ 36 mm, accompanied by right heart volume overload
- •The distance from the defect margin to the coronary sinus, inferior vena cava, superior vena cava, and pulmonary veins is ≥ 5 mm; the distance to the atrioventricular valve is ≥ 7 mm
- •Contraindications to radiation exposure or refusal to undergo fluoroscopy-guided procedures
- •Exclusion Criteria:
- •Associated cardiac malformations requiring surgical intervention
- •Right-to-left shunt ASD
- •Ostium primum ASD and sinus venosus ASD
- •Any severe infection within one month before the procedure
- •Intracardiac thrombus
研究组 & 干预措施
Ultrasound-guided intervention with assistance of specialized instruments group
Patients randomized in this group will undergo percutaneous ASD closure under pure ultrasound guidance in the entire process with assistance of specialized instruments.
干预措施: Ultrasound-guided intervention with assistance of specialized instruments (Procedure)
fluoroscopy-guided intervention group
Patients randomized in this group will undergo percutaneous ASD closure under fluoroscopic guidance in the entire process
干预措施: fluoroscopy-guided intervention (Procedure)
cohort
Patients meet requirements but have contraindications to fluoroscopy, such as pregnancy, contrast allergy, malignancy, or thyroid dysfunction, are enrolled in the single-arm observational cohort to undergo echocardiography-guided ASD closure assistead by PannaWire
干预措施: Ultrasound-guided intervention with assistance of specialized instruments (Procedure)
结局指标
主要结局
Procedural success rate
时间窗: Immediately after implantation
Procedural success is defined as completion of the ASD closure without conversion to another guidance method or surgical repair under cardiopulmonary bypass, and with a residual shunt no greater than 2 mm immediately after implantation. Evaluation of the primary endpoint was done by specialized sonographers blinded to the intervention.
次要结局
- Successful closure rate(Immediately after implantation, at 30 days, at 3 months after implantation)
- Composite of major adverse events(At 3 months after implantation)
- Composite of minor adverse events(At 3 months after implantation)
- Procedure time(At discharge (assessed up to 3 months))
- Days of hospital stay(At discharge (assessed up to 3 months))
- Hospitalization cost(At discharge (assessed up to 3 months))
研究者
Pan Xiangbin
Principal Investigator
Chinese Academy of Medical Sciences, Fuwai Hospital